Jin Beixin (firsekibart) / GeneScience - LARVOL DELTA

An Open-Label, Single-Arm Exploratory Study Evaluating an IL-1 Inhibitor Combined with Etoricoxib as First-Line Therapy in Patients with Acute Gouty Arthritis (ChiCTR) - P4 | N=53 | Not yet recruiting | Sponsor: The First Hospital of Jilin University; The First Hospital of Jilin University

New P4 trial • Gout • Immunology • Inflammatory Arthritis • Rheumatology

To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis. (clinicaltrials.gov) - P=N/A | N=290 | Recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | N=221 ➔ 290

Enrollment change • Idiopathic Arthritis • Immunology • Rheumatology

Sustained remission in refractory Schnitzler syndrome presenting with prominent acropachy: from anakinra induction to firsekibart maintenance. (PubMed, Clin Rheumatol) - No abstract available

Journal

Evaluation of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Firsekibart in Gout: A Phase Ib/II Clinical Trial. (PubMed, Int J Rheum Dis) - P1/2 | "A single subcutaneous injection of Firsekibart is safe and well tolerated in the treatment of gout flares. It provides dose-dependent pain relief with favorable pharmacokinetic properties and potential for reducing the risk of gout flare recurrence."

Clinical • Journal • P1/2 data • PK/PD data • Gout • Inflammatory Arthritis • Pain • Rheumatology

Firsekibart in Complex and Refractory Gout Patients Unsuitable for Conventional Therapy: A Real-World Case Series. (PubMed, Int J Rheum Dis) - No abstract available

Journal • Real-world evidence • Gout • Inflammatory Arthritis • Rheumatology

Exploration of the efficacy and safety of IL - 1 inhibitors in the treatment of systemic sclerosis (ChiCTR) - P4 | N=15 | Not yet recruiting | Sponsor: Affiliated Hospital of North Sichuan Medical College; Affiliated Hospital of North Sichuan Medical College

New P4 trial • Immunology • Scleroderma • Systemic Sclerosis

Efficacy and Safety of Firsekibart in Combination with Intravenous Immunoglobulin and Aspirin versus Intravenous Immunoglobulin and Aspirin Alone in the Treatment of Kawasaki Disease: A Prospective Concurrent Controlled Study (ChiCTR) - P=N/A | N=60 | Recruiting | Sponsor: Children's Hospital of Nanjing Medical University; Children's Hospital of Nanjing Medical University

New trial

Bioequivalence of Two Firsekibart Subcutaneous Formulations: A Randomized, Double-Blind, Single-Dose, Parallel-Group Study in Healthy Chinese Participants. (PubMed, Clin Pharmacol Drug Dev) - "Most treatment-emergent adverse events were mild/moderate and generally comparable between T and R, with no treatment-related serious adverse events reported. Firsekibart solution for injection was bioequivalent to firsekibart lyophilized powder for solution for injection in healthy Chinese males, with no new safety signals identified."

Clinical • Journal

Efficacy and Safety of IL-1 Inhibitors in Mild to Moderate Systemic Lupus Erythematosus (clinicaltrials.gov) - P4 | N=15 | Active, not recruiting | Sponsor: Chinese SLE Treatment And Research Group | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Clinical response to firsekibart in a 73-year-old patient with tophaceous gout complicated by prostate cancer and chronic kidney disease: a case report. (PubMed, Transl Androl Urol) - "Urate-lowering therapy with febuxostat was subsequently introduced. This case suggests that firsekibart may provide rapid and effective inflammation control in high-risk gout populations where standard treatments are limited. These findings highlight the potential of IL-1β targeted therapy as a precision medicine approach for complex patients; however, larger prospective studies are required to validate the long-term oncological and renal safety profile of firsekibart in this population."

Journal • Cardiovascular • Chronic Kidney Disease • Coronary Artery Disease • Genito-urinary Cancer • Gout • Hypertension • Infectious Disease • Inflammatory Arthritis • Musculoskeletal Diseases • Musculoskeletal Pain • Nephrology • Oncology • Pain • Prostate Adenocarcinoma • Prostate Cancer • Renal Disease • Rheumatology • Solid Tumor • CRP • IL1B

Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease (clinicaltrials.gov) - P2/3 | N=90 | Not yet recruiting | Sponsor: Children's Hospital of Fudan University

New P2/3 trial

Efficacy and Safety of Scheduled Versus As-Needed Firsekibart Administration for the Prevention of Gout Recurrence: A Multicenter, Open-Label, Randomized Controlled Trial (clinicaltrials.gov) - P=N/A | N=118 | Not yet recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New trial • Gout • Inflammatory Arthritis • Rheumatology

24-Week Recurrence Rate of Gout Following Firsekibart Treatment (clinicaltrials.gov) - P=N/A | N=264 | Not yet recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New trial • Real-world evidence • Gout • Immunology • Inflammatory Arthritis • Rheumatology

Real-world effectiveness and safety of firsekibart versus compound betamethasone in frequent gout flares: a multicenter retrospective study. (PubMed, Clin Rheumatol) - "In this real-world study of patients with frequent flares, firsekibart showed comparable analgesic efficacy to compound betamethasone and was associated with superior sustained flare prevention and acceptable safety. These findings suggest firsekibart may be a potential treatment option for patients with limited alternatives, though larger studies are warranted. Key Points • This study provides the first real-world evidence of firsekibart in acute gout flares. • Firsekibart showed comparable pain relief to compound betamethasone at 48 h. • Firsekibart reduced new flare risk by 88% within 24 weeks. • Firsekibart had an acceptable safety profile with no serious infections."

Journal • Real-world evidence • Retrospective data • Gout • Infectious Disease • Inflammation • Inflammatory Arthritis • Pain • Rheumatology • IL1B

Acute gout attack in a peritoneal dialysis patient treated with Firsekibart: a case report. (PubMed, Open Med (Wars)) - "No injection site reactions, hypersensitivity, or infectious complications were observed throughout the entire follow-up period. IL-1β blockade Firsekibart may represent a safe and effective option for managing acute gout attacks in high-risk ESRD patients on PD with multiple comorbidities."

Journal • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Gout • Heart Failure • Hematological Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Renal Disease • Respiratory Diseases • Rheumatology • CRP • IL1B

Efficacy and Safety of Firsekibart in Patients with Acute Gout Unsuitable for Standard Therapy: 48-Week Results from an Open-Label Extension of a Randomized Phase 3 Trial. (PubMed, Adv Ther) - P3 | "In this open-label extension study, firsekibart demonstrated sustained efficacy in reducing gout flare recurrence through 48 weeks, with a consistent and favorable safety profile, and no new safety signals identified during extended follow-up."

Clinical • Journal • P3 data • Gout • Immunology • Inflammatory Arthritis • Pain • Rheumatology • IL1B

Population pharmacokinetics and exposure-response modelling of firsekibart (GenSci048) in patients with acute gout flare: Implications for fixed-dose optimization. (PubMed, Br J Clin Pharmacol) - "Firsekibart demonstrated predictable pharmacokinetics, a favourable safety profile, and robust efficacy coverage at the 200-mg fixed dose. These findings support fixed-dosing for patients with acute gout flares who are intolerant of, unsuitable for, or inadequately responsive to standard-of-care therapies."

Journal • PK/PD data • Dyslipidemia • Gout • Hepatology • Inflammatory Arthritis • Liver Failure • Renal Disease • Rheumatology • IL1B

COST EFFECTIVENESS OF FIRSEKIBART FOR THE TREATMENT OF ACUTE GOUT PATIENTS UNSUITABLE FOR STANDARD THERAPY IN CHINA (ISPOR 2026) - "Firsekibart was cost-effective compared with compound betamethasone in the Chinese setting, which is mainly due to its superiority in preventing flares. The results could inform deliberations regarding reimbursement and access to this treatment in China."

Clinical • Cost effectiveness • HEOR • Gout • Inflammatory Arthritis • Rheumatology

Clinical Effectiveness and Safety of IL-1 Inhibitors Plus Urate-Lowering Therapy Compared to Conventional Treatment in Patients with Refractory Gout: A Real-World Study (ChiCTR) - P=N/A | N=56 | Sponsor: Tianjin Medical University Chu Hsien-I Memorial Hospital; Tianjin Medical University Chu Hsien-I Memorial?Hospital

New trial • Real-world evidence • Gout • Inflammatory Arthritis • Rheumatology

Clinical trial on the Efficacy and Safety of an IL‑1 Inhibitor in Elderly Patients With Gouty Arthritis (ChiCTR) - P4 | N=22 | Sponsor: Hebei General Hospital; Hebei General Hospital

New P4 trial • Immunology • Inflammatory Arthritis • Rheumatology

A multicenter, prospective, basket interventional study of vixencizumab in the treatment of CAPS, FMF, Schnitzler syndrome and AOSD (ChiCTR) - P=N/A | N=90 | Sponsor: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

New trial • NLRP3

A Clinical Trial of Firsekibart, Tislelizumab, and Lenvatinib in Patients With Unresectable, TP53-Mutated Hepatocellular Carcinoma (clinicaltrials.gov) - P=N/A | N=25 | Not yet recruiting | Sponsor: Tongji Hospital

New trial • Hepatocellular Cancer • Oncology • Solid Tumor • TP53

A Study of Firsekibart Versus Anakinra in Adult-Onset Still's Disease (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Ruijin Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology

Firsekibart for steroid withdrawal in glucocorticoid-dependent refractory gout: a case report. (PubMed, Front Immunol) - "Inflammatory markers normalized, renal function stabilized, and serum urate decreased. This case demonstrates the potential of firsekibart as a potent steroid-sparing agent, effectively breaking the cycle of glucocorticoid dependency in refractory gout and enabling successful long-term management."

Journal • Gout • Inflammatory Arthritis • Rheumatology • IL1B

Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: Tongji Hospital

New trial • Immunology • Scleroderma • Systemic Sclerosis